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FDA 510(k)

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

Número K: K183375 · 2019-02-12

RequerenteHoriba, Ltd.
Data da decisão2019-02-12
Código do produtoJJE
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Horiba, Ltd.. It received FDA 510(k) clearance on 2019-02-12 under 510(k) number K183375. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is a medical device that received FDA 510(k) clearance on 2019-02-12. The listed applicant is Horiba, Ltd.. The 510(k) number is K183375.

When did Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode receive FDA 510(k) clearance?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode received FDA 510(k) clearance on 2019-02-12, under 510(k) number K183375.

Who is the listed applicant for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

The FDA 510(k) record lists Horiba, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

The FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is JJE.

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